The Effect Of Transcranial Direct Current Stimulation In Panic Disorder

NCT04160806 | Completed

• 1 other identifier: 2019-141
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the present study is to investigate the effect of prefrontal transcranial Direct Current Stimulation (tDCS) on clinical severity, attentional bias and interoceptive accuracy in panic disorder (PD). The participants will be assigned to active and sham groups (1:1) and will receive 10 sessions of tDCS. The study will also examine if the effects may last for a month.

Conditions

Panic Disorder

Keywords

Anxiety disorders; Panic disorder; Transcranial Direct Current Stimulation; Interoceptive accuracy; Attention bias; Emotion recognition; Brain Stimulation

Outcome Measures

Primary Outcomes (4)

• Changes in Panic Disorder Severity Scale (PDSS) scores

  The PDSS consists of seven items, each rated on a 5-point scale, which ranges from 0 to 4. The items assess panic frequency, resulting distress, panic-focused anticipatory anxiety, phobic avoidance of situations and of physical sensations, impairment in occupational and social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. Minimum score is 0 and maximum score is 28. Higher scores indicate high levels of panic symptomatology. Reduction in score from baseline indicates clinical improvement of panic symptoms.

  Up to one month

• Changes in Hamilton Anxiety Rating Scale (HAM-A) scores

  The Hamilton Anxiety Rating Scale (HAM-A) is a multiple item questionnaire used to provide an indication of anxiety severity. Higher scores indicate high levels of symptomatology. Minimum score is 0 and maximum score is 56. Reduction in score from baseline indicates clinical symptom improvement.

  Up to one month

• Changes in Clinical Global Impression-Severity (CGI-S) scores

  Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement. Minimum score is 1 and maximum score is 7. Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.

  Up to one month

• Changes in performance on an attentional dot-probe task

  Computerized "dot-probe " attentional task will be used. Pairs of emotional faces (neutral/angry or neutral/happy) are randomly presented on a screen. Then, a probe is presented. Subjects are asked to indicate which side the probe approved and need to press the dot after the probe. Total time spent on Region of Interest (angry/neutral face) is measured. Attentional bias towards threat score is the subtraction of median reaction times (milliseconds) in congruent angry versus neutral trials from incongruent angry versus neutral trials. Minimum score is -1000 and maximum score is 1000. Positive scores indicate the presence of attentional vigilance towards threat whereas negative scores indicate an attentional avoidance towards threat.

  Up to one month

Secondary Outcomes (8)

• Changes in Hamilton Depression Rating Scale (HAM-D) scores

  Up to one month

• Changes in Beck Depression Inventory (BDI) scores

  Up to one month

• Changes in Sheehan Disability Scale (SDS) Work/School scores

  Up to one month

• Changes in Sheehan Disability Scale (SDS) Social Life scores

  Up to one month

• Changes in Sheehan Disability Scale (SDS) Family Life/Home Responsibilities scores

  Up to one month

Study Arms (2)

Active Group

ACTIVE COMPARATOR

Left anodal/right anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex

Device: Transcranial direct current stimulation

Sham Group

SHAM COMPARATOR

Sham transcranial direct current stimulation over the dorsolateral prefrontal cortex

Device: Transcranial direct current stimulation

Interventions

Transcranial direct current stimulation DEVICE

Participants will receive a total of 10 stimulation sessions. During each session, 2 milliAmpers of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (left anodal/right anodal).

Also known as: tDCS, Direct current stimulation, transcranial electrical stimulation

Active Group; Sham Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with a primary diagnosis of Panic Disorder, as confirmed by the Structured Clinical Interview for the DSM-5 (SCID-5);
• Patients currently on medication must be at the same stable dose(s) for one month prior to enrollment and be willing to continue at the same dose(s) through the duration of the study;
• Right-hand dominancy assessed by Edinburgh Handedness Inventory;
• Willingness and ability to comply with the requirements of the study protocol;
• Naïve to tDCS.
• or more years of education

You may not qualify if:

• Illiteracy, deficient language or refusal to participate or being not able to follow instructions or complete study tasks;
• Less than 5 years of education
• Individuals with any current or lifetime diagnosis of other Axis I disorders, as confirmed by the Structured Clinical Interview for the DSM-5 (SCID-5);
• History of substance or psychoactive compound use,with the exception of nicotine consumption;
• The presence of mental retardation diagnosis (previously identified)
• Individuals with a clinically defined neurological disorder, with an increased risk of seizure for any reason, with a history of treatment with rTMS, deep brain stimulation for any disorder will be excluded;
• Any personal or family history (1st degree relatives) of seizures other than febrile childhood seizures
• Personal history of head trauma that resulted in loss of consciousness for \> 5 minutes and retrograde amnesia for \> 30 minutes;
• Significant hearing loss or visual impairment;
• Diagnosis of any serious or uncontrolled medical condition such as chronic obstructive pulmonary disease, congestive heart failure or renal failure;
• Skin diseases that could potentially cause irritations under electrodes;
• Patients missing two consecutive protocol sessions;
• Patients with cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed will be excluded.

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Department Of Psychiatry, Istanbul University

Istanbul, 34060, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Panic Disorder; Anxiety Disorders

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Raşit Tükel, Professor

  Istanbul University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 8, 2019
• First Posted: November 13, 2019
• Study Start: November 1, 2019
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)